(128 days)
BAT can be used for the positioning of patients that are prescribed external beam radiation treatments to organs which are readily identifiable on ultrasound images. BAT can be used for general imaging for small organs (breast, thyroid, testes), abdominal, trans-esophageal (noncardiac), trans-rectal, trans-vaginal, and musculo-skeletal (superficial and conventional) applications.
Not Found
I am sorry, but the provided text does not contain the acceptance criteria or a study proving the device meets those criteria. The document is an FDA 510(k) clearance letter for the BAT device, indicating that the device has been found substantially equivalent to a legally marketed predicate device for its indicated uses.
The letter lists the device name, regulation numbers, regulatory class, product codes, and the indications for use, but it does not detail:
- Specific acceptance criteria.
- Results of a performance study that quantitatively demonstrates the device meets certain metrics.
- Information about sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.
Therefore, I cannot provide the requested table and information based on the text provided.
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Image /page/0/Picture/0 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the text "U.S. HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle with three lines representing its wings and tail feathers.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
.JUL 1 1 2007
Ms. Marita Brust Vice President Quality Assurance NOMOS Corporation 200 West Kensinger Dr. CRANBERRY TOWNSHIP PA 16066
Re: K070611
Trade/Device Name: BAT Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYE and IYO Dated: June 14, 2007 Received: June 15, 2007
Dear Ms. Brust:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Image /page/0/Picture/10 description: The image shows a logo with the letters FDA in the center, surrounded by the words "Centennial" and "1906-2006". Below the logo is the text "Protecting and Promoting Public Health". The text is written in a decorative font. The image appears to be a scan of a document.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean I Teast oc advised that I Dris assume of that your device complies with other requirements of the Act that IDA has made a decemmandings administered by other Federal agencies. You must of any I Citial satures and regulations, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CrK in the quality systems (QS) regulation (2) CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter will anow you to begin mainer of substantial equivalence of your device to a legally premits the lineadon: The PDF inishingssification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your are of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology 240-276-0115 | |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894 xxx | (Radiology) ------------------------------------------------------------------------------------------------------------------------------------------------------------------ | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under (21CFN I all 807.77). Tountal Security of Small Status and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150
or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director. Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
510(k) Number (if known): _K070611
Device Name: BAT
Indications for Use:
BAT can be used for the positioning of patients that are prescribed external beam radiation treatments to organs which are readily identifiable on ultrasound images. BAT can be used for general imaging for small organs (breast, thyroid, testes), abdominal, trans-esophageal (noncardiac), trans-rectal, trans-vaginal, and musculo-skeletal (superficial and conventional) applications.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy Brogdon
(Division Sign-Off) / Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
Page 1 of 1
§ 892.5050 Medical charged-particle radiation therapy system.
(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.